Closed-Loop Insulin Delivery Effects on Glycemia During Sleep and Sleep Quality in Older Adults with Type 1 Diabetes: Results from the ORACL Trial
Anindita Chakrabarti, Steven Trawley, Erin Kubilay, Andisheh Mohammad Alipoor, Sara Vogrin, Spiros Fourlanos, Melissa H. Lee, David N. O’Neal, Niamh O’Regan, Vijaya Sundararajan, Glenn M. Ward, Richard J. MacIsaac, Peter G. Colman, Sybil A. McAuley
Abstract
Sleep-related effects of closed-loop therapy among older adults with type 1 diabetes have not been well established. In the OldeR Adult Closed-Loop (ORACL) randomized, crossover trial of first-generation closed-loop therapy (MiniMed 670G), participants wore actigraphy and completed sleep diaries for 14-day periods at stage end. During objectively measured sleep (actigraphy) with closed-loop versus sensor-augmented pump therapy, glucose time-in-range 70–180 mg/dL (3.9–10.0 mmol/L) was greater (90.3% vs. 78.7%, respectively; difference 8.2 percentage points [95% confidence interval {CI} 1.5 to 13.0]; P = 0.008), and there were fewer sensor hypoglycemia episodes (18 vs. 43, respectively; incident rate ratio 0.40 [95% CI 0.20 to 0.55]; P = 0.007). Sleep quality recorded daily was worse with closed-loop therapy ( P = 0.006); Pittsburgh Sleep Quality Index did not differ. There were 30% more system alarms during monitored sleep with closed-loop therapy ( P < 0.001). First-generation closed-loop therapy has important glycemic benefits during sleep for older adults, with deterioration in some sleep quality measures. Sleep quality warrants prioritization and investigation during advancement of closed-loop technology.